PICO Astrid van der Veldt Terugrapportage 6 maart 2012.

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1 PICO Astrid van der Veldt Terugrapportage 6 maart 2012

2 Outline Background PICO Search strategy Results search strategy Recommendations Protocol Internal Medicine VUmc

3 Silicone breast implants Available since early 1960s Five generations of silicone implants have been introduced In the Netherlands, number of women with breast implants is estimated at 30.000 Incidence rupture increases with implant age 15% rupture in 3 rd -10 th year after implantation Holmich et al, Arch Surg 2003.

4 Definition leakage silicone implants Shell = silicone rubber covering an implant Capsule = layer of scar tissue around implant Leak = small amount silicone passing through a hole in the shell Rupture= significant portion silicone lies outside the shell within the capsule Extrusion= displacement of silicone into adjacent tissues Dowden, AJR 1993.

5 Imaging silicone breast implants 1 Mammography + inexpensive - risk of rupture 2, radiation Ultrasound + inexpensive - operator-dependent, not reliable for free silicone particles 2, less accurate with capsular contracture MRI + reliable for severe capsular contracture, chest wall visible, better resolution of internal implant structure, best technique for intracapsular rupture - expensive 1 Samuels et al, Plast Reconstr Surg 1995. 2 Brown et al, J Womens Health 2004.

6 MRI breast implant Caskey et al, Radiographics 1999.

7 Silicone implants & systemic diseases No association with connective-tissue diseases or other autoimmune or rheumatic conditions 1 Association with anaplastic large-cell lymphoma 2 1 Janowsky et al, NEJM 2000. 2 De Jong et al, JAMA 2008.

8 Recommendations FDA 1-3 1976: silicone implants under FDA law left on the market until approval 1988:safety and efficacy needed to be proven by the manufacturers 1992:only approved for reconstruction 2006:implants of 2 manufacturers approved in USA →Recommendation: MRI at 3 years and every 2 years thereafter 3 1 Editorial, Lancet 2012. 2 Kuehn, JAMA 2011. 3 McCarthy et al, Plast Reconstruct Surg 2008.

9 Dringend advies NVPC en inspectie: PIP-protheses moeten worden verwijderd www.Mednet.nl Lijst ziekenhuizen met PIP prothese www. Rtl.nl Kanker bij 20 Franse vrouwen met PIP-prothesen Volkskrant 2012 NIV en NVPC starten onderzoek naar gezondheidsklachten siliconen prothesen BeautyJournaal.nl

10 PICO PPatiënt met een siliconen prothese en “vage” klachten op de polikliniek INW I MRI C Biopt O Sensitivity / specificity voor lekkage

11 Medline search strategy* ("Mammaplasty"[Mesh] OR mammaplasty[tiab] OR breast implant[tiab] OR breast implantation[tiab] OR breast implants[tiab]) AND ("Silicones"[Mesh] OR silicone*[tiab]) AND ("Rupture"[Mesh:noexp] OR "Prosthesis Failure"[Mesh:noexp] OR rupture*[tiab] OR leakage*[tiab]) AND ("Diagnostic Imaging"[Mesh] OR mri[tiab] OR ultrasound[tiab] OR diagnos*[tiab]) * With the help of Diewke Brand

12 Results search strategy Total abstracts(1981-2012)190 Case reports 41 Studies on US or MRI: -Retrospective studies -Small numbers of patients -No biopsy available

13 4 selected articles 1. Meta-analysis US & MRI (1998) 2. Meta-analysis MRI (2001) 3. Meta-analysis US & MRI (2011) 4. Decision-analysis in work-up (1998)

14 Meta-analyses (2x) 1 Cher et al, Ann Plast Surg 2001. 2 Goodman et al, Ann Plast Surg 1998.

15 Meta-analyses (2x) Cher et al. 1 Goodman et al 2 MRI Number of studies included186 Number of cases included2036 implants382 implants SettingMost symptomaticHeterogeneous Sensitivity78% Specificity91%80% 1 Cher et al, Ann Plast Surg 2001. 2 Goodman et al, Ann Plast Surg 1998.

16 Meta-analyses (2x) Cher et al. 1 Goodman et al 2 MRI Number of studies included186 Number of cases included2036 implants382 implants SettingMost symptomaticHeterogeneous Sensitivity78% Specificity91%80% US Number of studies included-6 Number of cases included-541 implants Setting-Heterogeneous Sensitivity-59% Specificity-77% 1 Cher et al, Ann Plast Surg 2001. 2 Goodman et al, Ann Plast Surg 1998.

17 Meta-analyses (2x) MRI studies using breast coils reported higher levels of accuracy 1 In lower prevalence populations, PPV (< 80%) insufficient to use MRI as screening tool 1,2 1 Cher et al, Ann Plast Surg 2001. 2 Goodman et al, Ann Plast Surg 1998.

18 Recent meta-analysis Song et al, Plast Reconstr Surg 2011. “The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis” Search strategy in: - Medline - EMBASE - ISI Web of Science - Cochrane

19 Details of search strategy Song et al, Plast Reconstr Surg 2011.

20 Inclusion criteria Song et al, Plast Reconstr Surg 2011.

21 Selected studies for meta-analysis Song et al, Plast Reconstr Surg 2011.

22 Accuracy of MRI and US SymptomaticAsymptomatic MRI Number of studies included113 Sensitivity (95% CI)88% (82-95%)76% (56-96%) Specificity (95% CI)94% (90-98%)68% (41-95%) Song et al, Plast Reconstr Surg 2011.

23 Accuracy of MRI and US SymptomaticAsymptomatic MRI Number of studies included113 Sensitivity (95% CI)88% (82-95%)76% (56-96%) Specificity (95% CI)94% (90-98%)68% (41-95%) US Number of studies included13 Sensitivity61% (53-68%) Specificity76% (68-83%) Song et al, Plast Reconstr Surg 2011.

24 General comments meta-analyses Definition silicone leakage: MRI vs. US Heterogeneous populations: - symptomatic vs. asymptomatic - age of the implant - time from imaging to explantation

25 Decision-analysis “Decision-analysis methodology in the work-up of women with suspected silicone breast implant rupture” Kevin et al, Plast Reconstr Surg 1998.

26 Decision-analysis Kevin et al, Plast Reconstr Surg 1998. Medline search Since 1994, 3 articles on sensitivity and specificity of US and MRI

27 Decision-analysis Kevin et al, Plast Reconstr Surg 1998. Based on literature the prevalence of rupture was estimated for: »Asymptomatic patients (6.5%) »Symptomatic patients, age implant < 10 years (31%) »Symptomatic patients, age implant > 10 years (64%)

28 Asymptomatic patients Kevin et al, Plast Reconstr Surg 1998.

29 Symptomatic patients Kevin et al, Plast Reconstr Surg 1998.

30 Conclusions decision-analysis Kevin et al, Plast Reconstr Surg 1998. For asymptomatic patients, US is the most efficient choice For symptomatic patients, the appropriate diagnostic algorithm will depend on the probability threshold established by the patient and the clinician

31 Conclusions PICO MRI breast in asymptomatic patients »Sensitivity: 76% (56-96%) »Specificity: 68% (41-95%) Use of MRI breast is uncertain as a screening tool in asymptomatic patients with silicone breast implants But what is “symptomatic”? Song et al, Plast Reconstr Surg 2011.

32 Recommendations More studies are needed to determine the use of MRI in the screening of asymptomatic patients with silicone breast implants The story of silicone implants indicates that post-market studies are essential to determine late and more rare adverse events of new devices

33 Aims protocol Internal Medicine VUmc 1.Bepalen van de incidentie van klachten gerelateerd aan de siliconen borstprothesen in Nederland 2.Onderzoeken van de kwaliteit van leven bij vrouwen met een siliconen borstprothese 3.Selecteren van individuele patiënten met uitgesproken systemische aandoeningen voor verder onderzoek 4.Bij patiënten met uitgesproken systemische aandoeningen inventariseren in hoeverre er lekkage van siliconen is 5.Patiënten met verdenking op een siliconen-geassocieerde systemische aandoening en bewezen lekkage randomiseren voor behandeling

34 Aims protocol Internal Medicine VUmc 1.Bepalen van de incidentie van klachten gerelateerd aan de siliconen borstprothesen in Nederland 2.Onderzoeken van de kwaliteit van leven bij vrouwen met een siliconen borstprothese 3.Selecteren van individuele patiënten met uitgesproken systemische aandoeningen voor verder onderzoek 4.Bij patiënten met uitgesproken systemische aandoeningen inventariseren in hoeverre er lekkage van siliconen is 5.Patiënten met verdenking op een siliconen-geassocieerde systemische aandoening en bewezen lekkage randomiseren voor behandeling

35 Protocol Internal Medicine VUmc Bij patiënten verwezen naar de polikliniek INW: Anamnese Lichamelijk onderzoek Laboratoriumonderzoek (z.n. ANA, ANCA etc) Echo en z.n. MRI (breast coil) bij symptomatische patiënten

36 Protocol Internal Medicine VUmc

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